Table 1

Inclusion and exclusion criteria for children with CMPA

Inclusion criteria	Exclusion criteria
Age between 1 and 5 years. Diagnosis of IgE-mediated CMPA confirmed according to ESPGHAN guidelines,24 by a positive OFC with CMPs. In high-risk children (ie, with a history of anaphylaxis),* diagnosis based on positive skin prick testing and/or elevated specific IgE to CMPs is sufficient. On a therapeutic elimination diet for at least 6 months or up to 12 months of age.11 Eligible regardless of the risk of systemic reaction (anaphylaxis) and asthma. Good overall health status. Parents without language barriers. Written informed consent signed by parents. Good cooperation with the child’s guardians.	Uncontrolled asthma, defined as the presence of shortness of breath, chest tightness, cough and/or auscultatory changes despite treatment. Signs of exacerbation of a chronic disease (ie, severe atopic dermatitis). Signs of acute infectious disease (ie, acute runny nose, cough or fever). Signs of exacerbation of another allergic disease (ie, conjunctivitis, allergic rhinitis, atopic dermatitis). Anaphylaxis due to CMPs in the last 6 months. Used antihistamines within 3–10† days before the challenge (depending on the pharmacokinetics of the drug and the indication for use). Documented tolerance to baked CMPs or higher steps of the milk ladder. Use of immunosuppressive drugs or immunotherapy.

Inclusion criteria

Exclusion criteria

Age between 1 and 5 years.
Diagnosis of IgE-mediated CMPA confirmed according to ESPGHAN guidelines,24 by a positive OFC with CMPs. In high-risk children (ie, with a history of anaphylaxis),* diagnosis based on positive skin prick testing and/or elevated specific IgE to CMPs is sufficient.
On a therapeutic elimination diet for at least 6 months or up to 12 months of age.11
Eligible regardless of the risk of systemic reaction (anaphylaxis) and asthma.
Good overall health status.
Parents without language barriers.
Written informed consent signed by parents.
Good cooperation with the child’s guardians.

Uncontrolled asthma, defined as the presence of shortness of breath, chest tightness, cough and/or auscultatory changes despite treatment.
Signs of exacerbation of a chronic disease (ie, severe atopic dermatitis).
Signs of acute infectious disease (ie, acute runny nose, cough or fever).
Signs of exacerbation of another allergic disease (ie, conjunctivitis, allergic rhinitis, atopic dermatitis).
Anaphylaxis due to CMPs in the last 6 months.
Used antihistamines within 3–10† days before the challenge (depending on the pharmacokinetics of the drug and the indication for use).
Documented tolerance to baked CMPs or higher steps of the milk ladder.
Use of immunosuppressive drugs or immunotherapy.

*In cases of severe anaphylactic reactions and high levels of specific IgE to CMPs, an OFC may be bypassed due to the elevated risk of anaphylaxis, which is contraindicated for OFC according to guidelines.11
†A time-limited contradiction (relative exclusion criterium).
CMPA, cow’s milk protein allergy; CMPs, cow’s milk proteins; ESPGHAN, European Society for Paediatric Gastroenterology Hepatology and Nutrition; IgE, immunoglobulin E; OFC, oral food challenge.